MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OLYMPUS ENDOSCOPE REPROCESSOR

Model Number OER-6

Device Problems Device Alarm System (1012); Device Reprocessing Problem (1091)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for an evaluation.According to the information provided, the last time the water filter was replaced was in october 2021.The customer was asked to clean the water level sensor and restart the process.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.

Event Description

It was reported to olympus through a call from the facility staff that an error e01 was displayed on the oer-6.After checking, it turns out that the water filter has not been replaced for a long time.It was also reported that the facility side cleaned the scope (gif-xp260n, gif-xp290n, pcf-pq260i) with oer-6 and used it for the patient.There was no injury or health damage due to the reported event.

Event Description

According to the initial reporter, the facility¿s staff had reprocessed three different scopes using the subject device (see below devices).Gif-xp260n (0 occurrences of use).Pcf-pq260i (29 occurrences of use).Gif-xp290n (157 occurrences of use).The customer went on to confirm that the last time the water filter was replaced was in october of 2021.Reportedly, the water filter involved was an olympus maj-2317.The customer provided additional information which confirmed the water filter was not replaced due to low awareness of cost and replacement of the water filter.This report is being submitted for the following event: replacement of the water filter was overdue.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and corrections to b5.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was not returned for evaluation.However, based on the results of the investigation, the water filter had not been replaced since october 2021 and it¿s likely this occurred due to the user¿s mishandling of replacing the water filer in accordance with the instructions for use.A final root cause was unable to be identified.The event can be detected/prevented by following the instructions for use which state: ¿the section 7.3 ¿replacing the water filter (maj-2317)¿ in the instruction manual describes preventive actions.¿ for reference to related events, please see reports with the following patient identifiers: pcf-pq260i: (b)(6).Gif-xp290n: (b)(6).Maj-2317:(b)(6).29 occurrences of incorrect reprocessing then use of pcf-pq260i: (b)(6.) 157 occurrences of incorrect reprocessing then use of gif-xp290n: (b)(6).Olympus will continue to monitor field performance for this device.

• Brand Name: OLYMPUS ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16399518
• MDR Text Key: 310234299
• Report Number: 9610595-2023-02757
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1